Table 3.
Immunogenicity End Points | LGG N=19 | PLACEBO N=20 | P value |
---|---|---|---|
Response to A/Solomon Islands/3/2006 (H1N1)- like | |||
Baseline | |||
Subjects with HAI titer ≥40 - % (95% CI) | 37% (16–62%) | 45% (23–68%) | 0.61 |
Geometric mean titer (95% CI) | 22 (11–44) | 22 (13–39) | 0.94 |
Day 28 After vaccination | |||
Subjects with HAI titer ≥40 - % (95% CI) | 42% (20–67%) | 50% (27–73%) | 0.62 |
Geometric mean titer (95% CI) | 26 (13–50) | 25 (14–48) | 0.98 |
Seroconversion | |||
Subjects with seroconversion*- % (95% CI) | 8% (0–38%) | 27% (6–61%) | 0.32 |
Response to A/Wisconsin/67/2005 (H3N2)- like | |||
Baseline | |||
Subjects with HAI titer ≥40 - % (95% CI) | 58% (34–80%) | 40% (19–64%) | 0.26 |
Geometric mean titer (95% CI) | 45 (23–88) | 28 (14–59) | 0.35 |
Day 28 After vaccination | |||
Subjects with HAI titer ≥40 - % (95% CI) | 84% (60–97%) | 55% (32–77%) | 0.048 |
Geometric mean titer (95% CI) | 72 (39–131) | 51 (26–100) | 0.43 |
Seroconversion | |||
Subjects with seroconversion*- % (95% CI) | 63% (24–91%) | 33% (10–65%) | 0.36 |
Response to B/Malaysia/2506/2004 – like | |||
Baseline | |||
Subjects with HAI titer ≥40 - % (95% CI) | 37% (16–61%) | 25% (6–44%) | 0.42 |
Geometric mean titer (95% CI) | 25 (16–39) | 19 (14–28) | 0.36 |
Day 28 After vaccination | |||
Subjects with HAI titer ≥40- % (95% CI) | 53% (29–76%) | 45% (23–68%) | 0.63 |
Geometric mean titer (95% CI) | 31 (24–41) | 25 (17–36) | 0.31 |
Seroconversion | |||
Subjects with seroconversion *- % (95% CI) | 42% (15–72%) | 40% (16–68%) | 1.00 |
Proportion of subjects with baseline titers < 1:40 who had follow-up titers of ≥ 1:40 or a fourfold increase from baseline at 14, 28 or 56 days after vaccination.